FAACT

Alerts

The alerts below provide information gathered from public notices and press releases about food allergen related recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. FAACT will only post recalls and alerts reported by the FDA, USDA, and manufacturers regarding the top 8 food allergens recognized by the FDA. FAACT will not post non-food items with the exception of medications, under the advisement of our Medical Advisory Board. See Archives to sort by specific allergen.

* Is It Really FDA-approved?

* IMPORTANT MESSAGE FROM THE FDA: May 21, 2015: What FDA Learned About Dark Chocolate and Milk Allergies

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Blog Entries - tag: 'Seeds'

U.S. FDA Approves Kaléo’s AUVI-Q® (Epinephrine Injection, USP) 0.1 mg AutoInjector for Life-Threatening Allergic Reactions in Infants and Small Children

Posted on: November 20, 2017 8:00 am
Tags: Peanuts, Milk, Egg, Tree-nuts, Soy, Fish, Gluten, Shellfish, Seeds, Sesame,
-- First and only epinephrine auto-injector (EAI) approved with a needle length and dose specifically designed for infants and children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) -- Anaphylaxis and food allergies increasing in children; read more …

Kaléo Donates Thousands of AUVI-Q® (epinephrine injection, USP) and EVZIO® (naloxone HCl Injection) Auto-injectors to Hurricane Harvey Relief Efforts

Posted on: September 1, 2017 12:00 pm
Tags: Peanuts, Milk, Egg, Tree-nuts, Wheat, Soy, Fish, Gluten, Shellfish, Seeds, Sesame,
-- Direct Relief to distribute 25,000 auto-injectors to partner clinics serving storm-impacted communities -- Richmond, VA (September 1, 2017) Kaléo, a privately-held pharmaceutical company, today announced a donation of 20,000 AUVI-Q® read more …

Hurricane Harvey Relief Efforts in Houston, SanAntonio, and More

Posted on: August 31, 2017 9:00 am
Tags: Peanuts, Milk, Egg, Tree-nuts, Wheat, Soy, Fish, Gluten, Shellfish, Seeds, Sesame,
Texas was hit very hard by Hurricane Harvey and the rain is still coming. San Antonio didn’t get much compared to other locations. Many of the people who have been evacuated from the coast are already here in San Antonio. We are expecting 10,000 more read more …

U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children

Posted on: July 27, 2017 9:00 am
Tags: Peanuts, Milk, Egg, Tree-nuts, Wheat, Soy, Fish, Gluten, Shellfish, Seeds, Sesame,
-- AUVI-Q® (epinephrine injection, USP) 0.1 mg could be the first auto-injector approved with a needle length and dose specifically designed for infants and small children -- -- Emergency room visits due to anaphylaxis are increasing in children read more …

KALÉO ANNOUNCES U.S. AVAILABILITY AND PRICING TO PATIENTS OF AUVI-Q® (Epinephrine Injection, USP) AUTO-INJECTOR, FOR LIFE-THREATENING ALLERGIC REACTIONS

Posted on: January 19, 2017 12:00 pm
Tags: Peanuts, Milk, Egg, Tree-nuts, Wheat, Soy, Fish, Shellfish, Sesame, Seeds, Gluten,
AUVI-Q will be available by prescription nationwide on February 14, 2017. Kaléo launches AUVI-Q AffordAbility, a first-of-its-kind access program and commitment for AUVI-Q: o More than 200 million Americans with commercial insurance, including those read more …

Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery

Posted on: October 28, 2015 4:00 pm
Tags: Peanuts, Milk, Egg, Tree-nuts, Wheat, Soy, Fish, Shellfish, Seeds, Gluten,
FOR IMMEDIATE RELEASE - October 28, 2015 - Bridgewater, N.J. - Sanofi US is voluntarily recalling all Auvi‑Q® (epinephrine injection, USP). The recall involves all Auvi‑Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for read more …

Enjoy Life Foods Conducts Nationwide Voluntary Recall of Single Lot of 10 oz. Semi-Sweet Chocolate Mini Chips Product Due to Undeclared Ingredients

Posted on: August 28, 2015 12:00 pm
Tags: Seeds
Schiller Park, Ill. – Aug. 28, 2015 – Enjoy Life Foods announced today a nationwide voluntary recall in the United States of a single production lot of the Enjoy Life Semi-Sweet Chocolate Mini Chips product (10 oz. bag) because some packages may read more …